A Study To Assess Effects Of PF-04958242 On Bold Functional Magnetic Resonance Imaging During Working Memory Activation And Arterial Spin Labeling At Rest In Healthy Subjects

Biogen112 enrolled

Overview

The primary objective of this study aims to determine whether the drug affects brain activity in healthy volunteers, either when the participants are performing a memory task, or when lying at rest. Subjects will undergo a brain scan under both of these conditions after a dose of either the study drug or a placebo is administered.The secondary objective is to evaluate the safety and tolerability of the four doses of PF-04958242 administered orally to healthy adult participants.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

112

Conditions

Healthy Volunteer

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter squared (kg/m2); * Total body weight \>50 kilograms (kg) (110 pounds \[lbs\]); Key Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing); * Positive urine drug screen; * Pregnant or nursing females, and females of child bearing potential; * Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Locations (2)

Research Site

New Haven, Connecticut, United States

Research Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Functional Magnetic Resonance Imaging Data During Working Memory Task

Time frame: 59 Minutes Post-dose

Arterial Spin Labeling Data

Time frame: 39 Minutes Post-dose

Secondary Outcomes

Number of Participants Experiencing Adverse Events and Serious Adverse Events

An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.

Time frame: Up to Day 11